(15 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware and basic processing.
No
The device measures bone mineral density and tissue mass, which are diagnostic measurements used by a physician, but it does not treat any condition.
Yes
The device measures bone mineral density and fat and lean tissue mass, and these values are compared to a reference population by a physician to provide an assessment, which falls under the definition of diagnosis.
No
The device description explicitly states it is a "full-featured general purpose x-ray bone densitometer system" consisting of a scan table, x-ray source, detector, and a computer workstation, along with a mechanical hardware mobile kit. This indicates it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit uses x-rays to measure bone mineral density and tissue mass directly within the body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes measuring bone density and tissue mass in a living patient, not analyzing biological samples.
Therefore, this device falls under the category of an in vivo diagnostic device, as it performs measurements within the living body.
N/A
Intended Use / Indications for Use
The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit provides an estimate of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.
The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit provide a measurement of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.
Product codes
KGI
Device Description
The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit is a full-featured general purpose x-ray bone densitometer system. It consists of a scan table that provides x-ray source generation, x-ray detection and processing. The user interface includes a computer workstation. This modification will provide users the option of mounting the bone densitometer system into a vehicle through the use of a mechanical hardware mobile kit used during the installation of the scanner and by the Operator during transport.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests: The device has been evaluated for safety, and has been found to conform with applicable medical device safety standards. In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications.
Clinical Tests: No clinical tests were required to establish safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K915535, K982267, K983564, K000826, K001756, K001812, K011917, K023554
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
SEP 1 4 2007
K 072439
Special 510(k) Premarket Notification
GE Medical Systems Lunar – DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit August 28th, 2007
510 (k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
GE Healthcare
Image /page/0/Picture/7 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular border. The logo is in black and white, with the letters and border appearing in white against a black background.
Section a):
| 1. | Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC division of
General Electric Company
GE Medical Systems Lunar (business name)
726 Heartland Trail
Madison, WI 53717 |
|----|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | James P. Raskob
Safety and Regulatory Engineering Manager
Telephone: 608-826-7425; Fax: 608-299-2132 |
| | Date Prepared: | August 28th, 2007 |
| 2. | Device Name: | GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit,
21 CFR 892.1170, 90-KGI |
| 3. | Marketed Device: | DPX and Prodigy series bone densitometers: K915535 K982267 K983564
K000826 K001756 K001812 K011917 K023554 currently in commercial
distribution. |
| 4. | Device Description: | The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile
Kit is a full-featured general purpose x-ray bone densitometer system. It
consists of a scan table that provides x-ray source generation, x-ray
detection and processing. The user interface includes a computer
workstation. This modification will provide users the option of mounting the
bone densitometer system into a vehicle through the use of a mechanical
hardware mobile kit used during the installation of the scanner and by the
Operator during transport. |
| 5. | Indications for Use: | The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit
provides an estimate of bone mineral density and fat and lean tissue mass. The
values can then be compared to a reference population at the sole discretion of |
the physician.
1
Special 510(k) Premarket Notification
GE Medical Systems Lunar ~ DPX and Prodiqy Series DEXA Bone Densitometers with Mobile Kit August 28th, 2007
6. Comparison with
| Predicate Device: The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile |
|---|
| Kit is of a comparable type and substantially equivalent to the current DPX and |
| Prodigy series bone densitometers. It has the same technological |
| characteristics, is comparable in key safety and effectiveness features, it |
| utilizes similar design, construction, and materials, and has the same intended |
| uses and basic operating modes as the predicate device. |
Section b):
-
- Non-clinical Tests: The device has been evaluated for safety, and has been found to conform with applicable medical device safety standards. In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications.
-
- Clinical Tests: No clinical tests were required to establish safety or effectiveness.
-
- Conclusion: Intended uses and other key features are consistent with previously cleared bone densitometers. The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance was verified through independent evaluation with ongoing factory surveillance. The GE Lunar DPX and Prodigy Series DEXA Bone Densitometer with Mobile Kit is substantially equivalent to currently marketed devices. No new safety and effectiveness questions are raised with the GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit option.
2
Image /page/2/Picture/0 description: The image shows a logo on the left and the word "DEPARTMENT" on the right. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The word "DEPARTMENT" is in a bold, sans-serif font, and it appears to be part of a larger heading or title.
SEP 1 4 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. James P. Raskob Safety and Regulatory Engineering Manager GE Medical Systems Lunar GE Healthcare 726 Heartland Trail MADISON WI 53717
Re: K072439
Trade/Device Name: GE Lunar DPX and Prodigy Series DEXA Bone Densitometer with Mobile Kit Regulation Number: 21 CFR 892.1190 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: August 28, 2007 Received: August 30, 2007
Dear Mr. Raskob:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. Below the logo, there is some text in a decorative font that reads "Protecting and Promoting Public Health."
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy Chrogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Special 510{k} Premarket Notification GE Medical Systems Lunar – DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit August 28th, 2007
Attachment E
Indications for Use
The GE Lunar DPX and Prodigy Series DEXA Bone Densitometers with Mobile Kit provide a measurement of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(P) EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Lewen
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K072439